Class 2 Device Recall Allura XPER FD20

• Date Initiated by Firm: December 10, 2008
• Date Posted: September 24, 2009
• Recall Status: Terminated on August 17, 2012
• Recall Number: Z-0349-2009
• Recall Event ID: 50742
• 510(K)Number: K033737
• Product Classification: Angiographic X-Ray System - Product Code IZI
• Product: Allura XPER FD20
• Code Information: FCO 72200107, 72200112, and 72200117 for 1st phase 72200132 for 2nd phase Equipment #'s 86914, 102166, 103282, 103380, 105294, 105670, 505876, 506539, 506540, 506778, 519195, 519894, 520319, 520491, 520598, 520630, 520631, 520632, 520660, 520755, 520779, 520783, 520814, 520948, 520977, 521001, 521154, 521222, 521311, 521312, 521314, 521315, 521512, 521548, 521589, 521659, 521675, 521820, 521890, 522397, 530368, 530391, 530392, 530485, 530584, 530663, 530664, 530666, 530715, 530783, 531728, 531752, 531760, 531762, 531808, 531817, 531830, 531834, 531931, 531943, 531944, 531945, 531946, 531948, 531949, 531951, 531957, 531961, 532077, 532150, 532207, 532225, 532227, 532239, 532244, 532245, 532249, 532262, 532263, 532264, 532294, 532532, 532533, 532649, 532990, 533084, 533284, 533285, 533287, 533325, 533395, 533398, 533543, 533551, 533738, 533763, 533772, 533857, 533897, 533955, 533956, 533966, 534108, 534131, 534150, 534152, 534158, 534215, 534217, 534232, 534246, 534250, 534255, 534269, 534270, 534374, 534380, 534418, 534420, 534431, 534452, 534545, 534565, 534569, 534639, 534646, 534665, 534682, 534716, 534720, 534724, 534730, 534787, 534796, 534798, 534810, 534811, 534856, 534927, 535094, 535151, 535152, 535173, 535213, 535274, 535278, 535285, 535303, 535367, 535376, 535396, 535418, 535424, 535439, 535492, 535566, 535611, 535615, 535635, 535702, 535727, 535772, 535779, 535793, 535813, 535814, 535927, 535931, 535946, 535951, 535982, 536006, 536007, 536014, 536030, 536067, 536136, 536154, 536155, 536163, 536173, 536174, 536178, 536234, 536433, 536471, 536592, 536641, 536646, 536714, 536717, 536736, 536796, 536798, 536801, 536901, 536921, 536954, 536993, 537024, 537073, 537118, 537205, 537266, 537268, 537296, 537357, 537386, 537466, 537514, 537590, 537597, 537604, 537717, 537743, 537784, 537805, 537810, 537838, 537854, 537922, 537934, 537938, 537985, 538102, 538193, 538194, 538228, 538234, 538322, 538369, 538386, 538404, 538406, 538449, 538464, 538465, 538466, 538479, 538482, 538512, 538538, 538771, 538813, 538902, 538910, 538911, 539094, 539204, 539220, 539267, 539268, 539322, 539323, 539369, 539380, 539381, 539398, 539456, 539472, 539479, 539634, 539745, 540048, 540082, 540150, 540167, 540203, 540209, 540213, 540275, 540284, 540288, 540312, 540321, 540325, 540338, 540374, 540421, 540456, 540460, 540487, 540622, 540684, 540721, 540790, 540808, 540887, 540912, 540930, 540952, 540973, 541030, 541046, 541047, 541049, 541053, 541223, 541237, 541238, 541239, 541251, 541253, 541259, 541509, 541572, 541659, 541715, 541742, 541748, 541783, 541848, 541873, 541880, 542306, 542382, 542478, 542486, 542518, 542522, 542526, 542744, 543087, 543213, 543216, 543229, 543386, 543397, 543398, 543399, 543444, 543611, 543759, 543762, 543799, 543850, 543877, 543931, 543971, 543972, 543984, 544005, 544052, 544057, 544086, 544103, 544120, 544130, 544184, 544371, 544489, 544513, 544550, 544581, 544631, 544636, 544655, 544728, 544729, 544750, 544989, 545024, 545073, 545090, 545262, 545280, 545282, 545293, 545295, 545521, 545539, 545640, 545714, 545733, 545749, 545750, 545752, 545776, 545779, 545799, 545827, 545838, 545839, 545840, 545853, 545905, 545912, 545921, 545941, 545964, 545975, 545985, 545991, 546014, 546025, 546060, 546201, 546456, 546517, 546585, 546586, 546634, 546668, 546679, 546693, 546886, 546908, 547005, 547058, 547118, 547234, 547287, 547334, 547364, 547392, 547601, 547619, 547620, 547621, 547627, 547628, 547700, 547720, 547729, 547748, 547753, 547770, 547775, 547777, 547795, 547800, 547822, 547833, 547838, 547852, 547855, 547861, 547893, 547896, 547898, 547918, 547921, 547925, 547932, 547948, 547952, 547976, 547977, 548022, 548029, 548039, 548049, 548051, 548054, 548061, 548108, 548192, 548496, 548601, 548616, 548640, 548660, 548764, 548775, 548778, 548785, 549170, 549245, 549250, 549252, 549253, 549264, 549306, 549378, 549379, 549385, 549750, 549902, 549925, 549967, 550031, 550053, 550122, 550133, 550173, 550244, 550253, 550304, 550371, 550399, 550404, 550451, 551050, 551051, 551146, 551178, 551340, 551370, 551607, 551608, 551725, 551763, 551851, 551853, 552178, 552192, 552202, 552279, 552381, 552382, 552425, 552440, 552469, 552546, 552590, 552736, 553097, 553288, 553330, 553397, 553432, 553445, 553466, 553486, 553487, 553603, 553697, 553723, 553798, 553803, 553846, 553867, 553868, 553869, 553871, 553873, 553881, 553984, 554008, 554018, 554044, 554049, 554054, 554136, 554370, 554447, 554518, 554680, 554731, 554763, 554775, 554776, 554784, 554811, 555300, 555321, 555343, 555349, 555350, 555420, 555447, 555461, 555470, 555588, 555742, 555927, 556017, 556095, 556156, 556203, 556323, 556389, 556390, 556470, 556601, 556605, 556609, 556701, 556709, 556760, 556810, 556811, 556814, 556820, 556855, 556857, 556893, 557653, 557808, 558238, 558448, 558499, 558582, 558831, 558832, 558949, 41416356, 41443671, 41443928, 41444385, 41444398, 41444603, 41444646, 41444743, 41444747, 41444758, 41444791, 41444797, 41445010, 41445014, 41445070, 41445169, 41445202, 41445207, 41445261, 41445285, 41445309, 41445310, 41445385, 41445438, 41445452, 41445495, 41445502, 41445516, 41445582, 41445640, 41445649, 41445692, 41445701, 41445785, 41445786, 41445809, 41445817, 41445875, 41445978, 41445989, 41446007, 41446039, 41446117, 41446217, 41446223, 41446277, 41446292, 41446323, 41446808, 41455893, 41455896, 41455900, 41455902, 41455910, 41455924, 41455955, 41691748, 41755552, 41787786, 41792800, 41792812, 41793875, 41796153, 41851761, 41956849, 42028108, 42038023, 42057714, 42067696, 42095488, 42172062, 42197144, 42206171, 42288802, 42313004, 42365781, 42366186, 42552595, 42638525, 42668010, 42826856, 42826863, 42985101, and 43082872. Additional Equipment #s for Phase 2 - 10440, 10441, 14145, 38358, 38925, 41272, 50438, 76378, 80320, 82537, 84721, 86066, 86290, 86989, 100503, 100683, 100708, 100713, 100948, 101139, 101606, 101607, 101966, 102563, 102776, 103144, 103231, 103287, 103957, 104056, 104077, 504315, 546465, 555781, 557790, 557809, 557841, 557956, 558199, 560060, 36190293, 41443700, 41443707, 41443774, 41443855, 41444399, 41444446, 41444463, 41444558, 41444597, 41444753, 41445026, 41445119, 41445125, 41445233, 41445246, 41445254, 41445255, 41445256, 41445315, 41445336, 41445427, 41445434, 41445486, 41445578, 41445616, 41445676, 41445804, 41445916, 41446044, 41446150, 41446211, 41446363, 41446796, 41586608, 41630856, 41765492, 41779600, 41779610, 41792527, 42046538, 42063953, 42066520, 42225697, 42323439, 42394081, 42473102, 42478916, 42635362, 42635423, 42635426, 42638228, 42638512, 42811500, 42812038, 42823758, 42878485, 42878591, 42881036, 42881266, 42892018, 42892430, 42892474, 42919054, 42919085, 42967816, 42985218, 43082276, 43084042, 43084414, 43119111, 43120325, 43165011, 43180544, 43209312, 43209348, 43209356, 43230259, 43263118, 43320930, 43340698, 43392727, 43420965, 43421081, 43433587, 43438771, 43443629, 43445198, 43592438, 43594036, 43594037, 43613819, 43618965, 43622121, 43704085, 43708891, 43720519, 43720677, 43720776, 43721160, 43721256, 43848518, 43914262, 43971849, 43973609, 43973613, 44004308, 44004309, 44015656, 44038398, 44203373, 44642682, 44891499, 47455986, and 49408181.
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: 425-487-7602
• Manufacturer Reason for Recall: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C
• Quantity in Commerce: 835 units
• Distribution: Worldwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IZI